Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT07367100

A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke

Led by Neuravi Limited · Updated on 2026-05-08

74

Participants Needed

15

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess the safety and the effectiveness of the Adaptive Tip Catheter (ATC) used as a first line direct aspiration thrombectomy technique for patients suffering of an acute ischemic stroke.

CONDITIONS

Official Title

A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 90 years at the time of consent
  • Signs and symptoms of acute ischemic stroke in the anterior circulation treatable by endovascular thrombectomy
  • Endovascular treatment can begin within 24 hours from last known well time
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher
  • Baseline Alberta Stroke Program Early CT Score (ASPECTS) of 3 or higher
  • Signed and dated informed consent form or approved emergency procedure consent obtained
Not Eligible

You will not qualify if you...

  • Known pregnancy or breastfeeding
  • Life expectancy less than 90 days before stroke onset
  • Known bleeding disorders, coagulation factor deficiency, or oral anticoagulant therapy with INR greater than 3.0
  • Symptoms or imaging showing stroke in multiple vascular territories or bilateral stroke
  • Intracranial occlusion considered chronic by history or imaging
  • Recent or fresh hemorrhage seen on CT or MRI
  • CT or MRI showing brain swelling (mass effect)
  • Currently in another interventional clinical trial that may affect study results
  • Cerebral arterial disease affecting treatment or outcome (e.g., vasculitis)
  • Blood vessel blockages or narrowing preventing device access or requiring acute stenting
  • Excessive blood vessel twisting preventing catheter access
  • Baseline expanded thrombolysis in cerebral infarction (eTICI) score greater than 1

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

UZ Antwerpen

Edegem, Belgium, 2650

Actively Recruiting

2

Ghent University Hospital

Ghent, Belgium, 9000

Actively Recruiting

3

Universitair Ziekenhuis Leuven

Leuven, Belgium, 3000

Actively Recruiting

4

CHU Bordeaux

Bordeaux, France, 33076

Not Yet Recruiting

5

CHU Nantes

Nantes, France, 44093

Not Yet Recruiting

6

CHU Pitie Salpetriere

Paris, France, 75013

Not Yet Recruiting

7

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, France, 31059

Not Yet Recruiting

8

CHRU de Tours

Tours, France, 37000

Not Yet Recruiting

9

Universitaetsklinikum Heidelberg

Heidelberg, Germany, 69120

Not Yet Recruiting

10

Universitatsklinikum Schleswig Holstein Kiel

Kiel, Germany, 24105

Not Yet Recruiting

11

Universitaetsmedizin Mainz

Mainz, Germany, 55101

Not Yet Recruiting

12

Stadtisches Klinikum Solingen gemeinnutzige GmbH

Solingen, Germany, 42653

Not Yet Recruiting

13

Beaumont Hospital

Dublin, Ireland, 00000

Not Yet Recruiting

14

VUMC Amsterdam

Amsterdam, Netherlands, 1105 AZ

Withdrawn

15

Maastricht University Medical Centre

Maastricht, Netherlands, 6229 HX

Not Yet Recruiting

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Research Team

A

Adriana Popovici

CONTACT

A

Arnaud Nicolas, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke | DecenTrialz